Innovating and adapting to manage changes in the health product regulatory environment

April 14, 2021

by Maite Barthel, PFSCM Product Quality Assurance Officer based in the Netherlands.

Global health supply chain organizations must comply with laws and regulations relevant to their sector, scope of work, and business processes.

Owing to the complexity of the regulatory environment, health product Procurement Services Agents (PSAs), must implement robust quality processes, policies, and tools to avoid placing non-compliant products on the market.

Organizations must also continuously evaluate and update their processes, policies, and tools to accommodate regulatory changes which are prompted by new research and technologies, or unexpected global events like the COVID-19 pandemic.

Owing to COVID-19, the demand and the supply of health products has increased significantly.

To control and prevent nonconformity, international organizations and regulatory authorities have been releasing several new guidelines on the quality-, performance- and related standards to be met by supply chain organizations.

The diversity, and fluidity of the regulatory environment is a great driver of innovation for public health organizations. Supply chain and quality assurance (QA) professionals must be well-informed, and must stay abreast of all new regulatory developments.

The Partnership for Supply Chain Management (PFSCM) — a diversified supply chain solutions provider and PSA — is adept at managing regulatory changes, and in the light of COVID-19, has recently updated its product QA policy, and adopted a new digital knowledge management tool to further strengthen its product QA activities.

 

Evolving product QA policy

 

PFSCM’s QA policy recognizes World Health Organization prequalification mechanisms, and relies on assessments and decisions taken by international organizations and regulatory agencies. For those products that are outside the scope, PFSCM has defined quality requirements for different types of products to ensure that they meet performance-, quality-, and safety requirements. In doing so, we are required to keep abreast with all standards, guidelines and regulations that are applicable to the wide range of products that fall under medical devices.

PFSCM’s product QA policy is a living process that is continuously improved, and updated to stay aligned with the diversity of international policies and changing requirements.

 

Implementing new knowledge management tools

 

From PFSCM’s experience, the management of new information should be based on a defined process and not an empirical one. New and existing information must be tracked, compared and flagged for easy reference. For this implementation a real procedure with a specific tool can be a solution.

PFSCM has been working on developing a knowledge management repository, or library that will house standards and guidelines published by international, and regional bodies pertinent to scope of products procured and supplied by PFSCM.

Further, we are actively identifying, collecting, organizing, and storing these references in the library and tracking changes. For newly published ones, we assess the changes and determine its impact on current policies, procedures and practices.

Through this knowledge management library PFSCM ensures:

  • complete compliance with international standards at all levels,
  • access to information in a timely manner, and
  • knowledge sharing within the organization.

 

In future, as the tool is further refined, we will be able to easily compare and highlight the differences among regulations, federal codes and directives.

A better understanding-, and traceability of the changes, will enable us to maintain and improve our QA policy, processes, and tools to remain compliant. This new system will further strengthen PFSCM’s Quality Assurance Program and will improve its efficiency.

 


 

Maite Barthel, PFSCM Product Quality Assurance Officer based in the Netherlands.

Doctor of Pharmacy, MSc International Regulatory Affairs with a first master in Public Health.

French doctor of pharmacy with a major in regulatory affairs and a parallel education in Public Health, my background allows me, in addition to medical-technical expertise, to interpret health data in a specific regulatory environment. I have experienced in healthcare, drug development and supply chain.

 

 

 

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